Rhythm expects to achieve the following near-term milestones: Complete submission of a supplementary New Drug Application to the FDA seeking a label expansion to treat pediatric patients between 2 and younger than 6 years old in approved indications in the first half of 2024; Initiate Phase 1 trial of RM-718 in the first half of 2024; Announce DAYBREAK Stage 2 data in the second half of 2024; Complete enrollment in two or more substudies in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the second half of 2024; and Announce top-line data in the Phase 3 trial evaluating setmelanotide in hypothalamic obesity in the first half of 2025.
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